Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT06604234
Eligibility Criteria:
Inclusion Criteria:
1. Women in peri- and/or postmenopause period (up to 5 years after last menstruation) Perimenopause is defined as if changes in the menstrual cycle (such as longer or shorter cycles, absence of any menstrual cycle, or abnormally heavy or prolonged bleeding) have occurred in the previous 12 months.
2. Age 45-60 years.
3. Cervantes quality of life scale score ≥ 38 at the screening visit.
4. Willing to sign the informed consent.
5. Willing to maintain dietary or lifestyle habits during the study.
Exclusion Criteria:
1. Regular use of probiotics other than the probiotics under study (in the form of food supplements or in foods such as "bifidus" type yogurt) in the month prior to the baseline visit.
2. Use of oral or injectable antibiotics in the last month before the start of the study.
3. Women with history of hysterectomy (removal of the uterus) or ovariectomy (removal of the ovaries).
4. Diagnosis of active oncological disease.
5. Use of hormone replacement therapy (HRT), hormonal analogues or oral contraceptives in the 3 months prior to the start of the study.
6. Type 1 diabetes.
7. Untreated or unstable thyroid disease.
8. Diagnosis of severe renal, cardiac or hepatic disease.
9. Diagnosis of chronic gastrointestinal disease: inflammatory bowel disease (Crohns disease, ulcerative colitis), pancreatitis, short bowel syndrome.
10. Diagnosis of celiac disease
11. Regular intake of laxatives such as polyethylene glycol or irritant laxatives (bisacodyl, sennosides, sodium pyrosulphate) (+3 days/week).
12. Primary or secondary immunodeficiency: AIDS, immunoglobulin deficiency.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
60 Years
Study:
NCT06604234
Study Brief:
Protocol Section:
NCT06604234